Sat, 18 Nov 2017

Development of Metoprolol Tartrate Orally Disintegrating Tablets 50 mg using Design of Experiments.

 

Rakesh K. Patel1*, Mukesh C. Patel1, Mukesh R. Patel1,2

1. S.K.P.C.P.E.R., Dept. of Pharmacy, Ganpat university, Ganpat Vidyanagar, Mehsana-382711, India

2. Restech Pharmaceuticals, National highway no 8A, moraiya, Ahmedabad, India


 

ABSTRACT

The objective of the current study was to develop and optimize an orally disintegrating tablet formulation of Metoprolol tartrate which is an effective drug in the treatment of hypertension. Metoprolol tartrate orally disintegrating tablets were prepared by direct compression method using different ingredients such as Mannitol, Microcrystalline cellulose, Aspartame, Crospovidone, Sodium starch glycolate, Croscarmellose sodium, Powder flavours Strawberry, peppermint & orange, Colloidal silicon dioxide and Magnesium stearate. Tablets were evaluated for the physical properties, out of which disintegration time and wetting time were considered as responses in a 32 full factorial experimental plan. Results were statistically examined using design expert software and polynomial mathematical equations; found to be statistically significant (p<0.05) for disintegration time and wetting time data. The obtained results were used to generate optimized overlay plot. The physical data from the numerical optimization were verified and found to be very close to those predicted from the regression analysis. Accelerated stability study was also performed on the optimum formulation. All results were in accordance with the requirements of a orally disintegrating tablet.

Keywords: Metoprolol tartrate; orally disintegrating tablet; 32 full factorial design; Optimization


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